IPP-ON IPPONINSTP

GUDID 10381780125877

The IPP-ON set includes instruments to be used as a guide for Interphalangeal implants. The interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis of the lesser toes in case of rigid or semi-rigid hammertoe deformity, revision of failed arthroplasty or arthrodesis, and shortening due to length excess of the second toe.

NEWDEAL

General internal orthopaedic fixation system implantation kit
Primary Device ID10381780125877
NIH Device Record Keya35f8d66-2177-4c0e-b0df-74219b7b1f3a
Commercial Distribution Discontinuation2023-03-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameIPP-ON
Version Model NumberIPPONINSTP
Catalog NumberIPPONINSTP
Company DUNS536935331
Company NameNEWDEAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780125877 [Primary]
HIBCCM248IPPONINSTP1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPIN, FIXATION, SMOOTH

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10381780125877]

Moist Heat or Steam Sterilization

[10381780125877]

Moist Heat or Steam Sterilization

[10381780125877]

Moist Heat or Steam Sterilization

[10381780125877]

Moist Heat or Steam Sterilization

[10381780125877]

Moist Heat or Steam Sterilization

[10381780125877]

Moist Heat or Steam Sterilization

[10381780125877]

Moist Heat or Steam Sterilization

[10381780125877]

Moist Heat or Steam Sterilization

[10381780125877]

Moist Heat or Steam Sterilization

[10381780125877]

Moist Heat or Steam Sterilization

[10381780125877]

Moist Heat or Steam Sterilization

[10381780125877]

Moist Heat or Steam Sterilization

[10381780125877]

Moist Heat or Steam Sterilization

[10381780125877]

Moist Heat or Steam Sterilization

[10381780125877]

Moist Heat or Steam Sterilization

[10381780125877]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-05-02
Device Publish Date2015-09-24

Devices Manufactured by NEWDEAL

M248PANTAXLSET1 - PANTA XL2024-08-23 The PANTA XL nail set inclides instrumentation wich are used as a guide for the implantation of PANTA XL Nail system.The PANTA X
10381780125891 - PANTA2024-08-23 The complete PANTA removal set includes instruments to be used for the removal of all PANTA nail system.
10381780064381 - B-BOP2024-07-11 In case of severe deformities of the forefoot, the basal osteotomy may be preferable to the distal osteotomy as it promotes a gr
M248119580ND1 - I.CO.S®2024-04-03 The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 4.0mm compression screw h
M248119590ND1 - I.CO.S®2024-04-03 The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 6.5mm compression screw h
M248139107ND1 - METIS®2024-02-07 The metatarsal osteotome is used to cut the bone after the pre-cutting stage with the cutting guide, for the insertion of the im
M248529061ND1 - SURFIX®2023-09-18 This K-Wire of diameter 2.5 mm and of length 250 mm is used to guide the instrumentation and the screws.
10381780043317 - BASAL DORSAL PLATE2023-09-18 The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is

Trademark Results [IPP-ON]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IPP-ON
IPP-ON
79056207 3576532 Live/Registered
NEWDEAL
2007-12-13
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.